Pfizer Faces Numerous Lawsuits Over Lipitor Side Effects

Did Pfizer fail to warn the public that Lipitor may cause Type 2 diabetes or memory loss?

A fast-growing number of lawsuits have been filed by women who allege the drug maker knew about the possibility of such serious side effects associated with its blockbuster cholesterol-lowering pill, but never properly warned the public, according to Reuters.

In the past five months, the news service reviewed federal court filings that show lawsuits by women in the U.S., who say that Lipitor caused them to develop type-2 diabetes, jumped from 56 to almost 1,000. One attorney says the actual number of women represented in these lawsuits numbers approximately 4,000.

The filings began picking up two years ago, after the FDA warned that Lipitor and other statins were linked to incidents of memory loss and a “small increased risk” of diabetes. According to lawyers representing plaintiffs, women face a higher risk than men of developing diabetes from using Lipitor, and gain fewer benefits, Reuters writes.

The recent spike in lawsuits followed a decision by a federal judicial panel to consolidate all Lipitor diabetes lawsuits from around the country into a single federal courtroom in Charleston, S.C. Pfizer opposed the consolidation, arguing it would prompt copycat filings. The first case is scheduled to be tried next July.

Of course, product-liability lawsuits are commonplace in the pharmaceutical industry. But Reuters suggests two things may set this litigation apart. For one, Lipitor is the best-selling prescription drug ever, racking up global sales of more than $130 billion since arriving in pharmacies in 1996. More than 29 million people in the U.S. have been prescribed the pill.

At the same time, plaintiffs may have a complicating factor. How so? Well, the FDA emphasized the benefits of statins even as it warned of the risks. “Clearly, we think that the heart benefit of statins outweighs this small increased risk,” Amy Egan, deputy director for safety in the FDA’s Division of Metabolism and Endocrinology Products, said in this statement about diabetes when the labeling change was made two years ago.

So what this will likely come down to is the extent to which women face the risk of developing diabetes while taking Lipitor and whether that risk is, effectively, mitigated by the cardiovascular benefits, according to Reuters.

As for Pfizer, the drug maker tells us it doesn’t believe Lipitor caused the plaintiff to develop diabetes and argues women who are prescribed the pill to control cholesterol may share other risk factors that make them vulnerable to the disease, such as high blood pressure or obesity. And Pfizer says there is an “overwhelming consensus” in the medical community about benefits to be had from statins.

Lipitor, by the way, was one of the most widely advertised drugs by lawyers seeking clients during between July 2013 and November 2013, which was prior to the consolidation in federal court last February, according to the Silverstein Group, a consulting firm that tracks advertising spending by law firms. The suggestion is that advertising helped to account for the increased number of lawsuits filed.

For now, Pfizer has not set aside funds to cover potential judgments, according to its latest quarterly filing with the U.S. Securities and Exchange Commission (please see page 31).

But Michael Green, an expert in mass torts at the Wake Forest University School of Law, tells Reuters that he does not expect Pfizer to settle at this stage, given the major obstacle plaintiffs still face. They “have to show they were actually harmed by this agent,” he says. “That might be hard.”

Comments (5 of 85)

Chances are the mere fact you are taking Lipitor or other statin could mean you are a: 10 to 30 lbs overweight, do not exercise properly, combine this with a high carb diet and is it any wonder you get stage II. If you maintained your ideal weight, exercised you probably wouldn't even be on a statin in the first place. The American diet is far more responsible for Stage II than Lipitor

9:37 pm August 12, 2014

doc brown wrote:

Mary there is no evidence that statins prevent a second heart attack plus you don't seem to have risk factors. You may wish to talk to your doctor about this.

5:22 pm August 12, 2014

mary murphy wrote:

i am taking lipitor for the last thirteen years after having a heart attack. i developed type two diabetes three years ago and there is no history of diabetes in my family.

3:41 pm August 12, 2014

Puppy! wrote:

My doc prescribed Lipitor for me. I took it for a few months and felt terrible, so I stopped and felt much better. My doc, however, insisted I resume taking it, so I told him I would, but I instead fed it to my dog. He liked it until about 8 days later when he exploded.

About Pharmalot

Pharmalot explores the fast-moving, complicated world that develops and markets medicines – and the drug makers that are attempting to replenish their pipelines while grappling with pricing and regulatory dictates, among many other challenges. Writer Ed Silverman has covered the pharmaceutical industry for nearly two decades and has closely followed the many hurdles facing drug companies as they move ideas from the laboratory to the medicine chest. He started Pharmalot while at The Star-Ledger of New Jersey and previously worked at New York Newsday and Investor’s Business Daily. Email Ed Silverman at ed.silverman@wsj.com, and follow him on Twitter @Pharmalot.